Gas conditioning trocars

ABSTRACT

A gas conditioning trocar having a chamber for heating and hydrating an unconditioned insufflation gas prior to injecting a conditioned insufflation gas into a body cavity during a medical procedure and a port through which surgical instruments can pass into a body cavity without inhibiting the flow of insufflation gas during the medical procedure.

FIELD OF THE INVENTION

This invention relates to the field of medical devices and morespecifically to a gas conditioning trocar for heating and/or hydratingan insufflation gas during a medical procedure.

BACKGROUND OF THE INVENTION

The concept of a medical apparatus for humidifying or otherwise treatinga gas from an insufflator during surgery is described in Douglas Ott etal. U.S. Pat. Nos. 5,411,474; 6,068,609 and 7,066,902. Briefly, aninsufflation gas is heated and hydrated i.e. conditioned, before the gasis directed into a body cavity through a device such as a trocar. Inorder to hydrate the insufflation gas a charge of hydration fluid istypically injected into a device where the hydration fluid can humidifythe insufflation gas and a heater can bring the insufflation gas to atemperature near body temperature. The conditioned insufflation gas isthen sent to a trocar for injection into a body cavity of a patient.

BRIEF SUMMARY OF THE INVENTION

Briefly, the invention comprises a gas conditioning trocar for on-the-goheating and/or hydrating of an insufflation gas immediately prior to itsuse in a medical procedure while allowing use of the trocar forinsertion of medical instruments therein.

The invention has several important technical advantages. Embodiments ofthe invention may have none, some, or all of these advantages.

The invention includes the ability to heat insufflation gas immediatelyprior to injecting the insufflation gas thereby minimizing heat lossesafter the insulation gas has been heated.

The invention includes the ability to hydrate the insufflation gasimmediately prior to injecting the insufflation gas thereby minimizingcondensation after the insufflation gas has been humidified.

A further advantage is that the hydration unit and the trocar form acompact easy to use disposable unit.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side partial sectional view of the trocar;

FIG. 2 is a top view of the trocar housing cover;

FIG. 3 is a side view of a multilayer media in an unwound condition;

FIG. 4 is top view of the multilayer media arranged in a spiralconfiguration; and

FIG. 4A is a cross sectional view taken along lines 4A-4A of FIG. 4.

DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 shows a partial cut away side view of a gas conditioning trocarfor on-the-go heating and/or hydrating of an insufflation gas during amedical procedure. Trocar 10 includes a cylindrical housing 12 having acannula 26 on one end and a cover 13 on the opposite end. The cannula 26comprises an elongated cylindrical tube for extending into a patient'sbody cavity. While not explicitly shown, cannula 26 may include a sharpmember for piercing the skin and tissue between the skin and theperitoneal cavity. Such a member may be spring loaded and may take manydifferent forms as understood by persons skilled in the art. Any form ofa sharp member may be used or the sharp member omitted without departingfrom the scope of the invention.

Cylindrical housing 12 and an upper coaxial tube 21 form an annularchamber 11 within trocar 10. Chamber 11 could have another shape withoutdeparting from the scope of the invention. Annular chamber 11 comprisesthree parts, an upper annular plenum chamber 11 a where insufflationfluids and insulation gas are introduced, a central annular chamber 11c, which may contain a conditioning media 20 for transporting theinsufflation gas and/or a hydration fluid threrethrough while bringingthe insufflation gas to a conditioned state as it enters the lowerannular plenum chamber 11 b. From plenum chamber 11 b the conditionedinsufflation gas flows into cannula 26 through an annular outlet port 21a.

Connected to one side of housing 12 may be a valve 18 for controllingthe flow of insufflation gas into upper annular plenum chamber 11 a andsimilarly connected to the opposite side of housing 12 may be a furthervalve 19, which may be a check valve, to control the flow of hydrationfluids into housing 12 as well as to prevent backflow of hydrationfluids. While mechanical valves are shown other types of controls may beused; for example, fluidic controls may be used to control the deliveryof fluids to the gas conditioning trocar. Either valve 19 or valve 18 orboth may be omitted without departing from the scope of the invention.The invention also includes trocars with multiple ports into housing 12where flow of gases and fluids into such ports is controlled by valvesin tubing leading to such ports. In this embodiment, junction box 16 ismounted on the side of housing 12 and contains electrical leads 14 froma heater located in the conditioning media 20. Junction box 16 can beomitted without departing from the scope of the invention. In someembodiments, the heater may be omitted. In other embodiments,conditioning media 20 may be omitted. Typically, the hydration fluid maybe water, however, other fluids may be included in addition to orinstead of the water. For example, a saline solution, an anesthetic, anantibiotic, or other pharmacologic agent could be used.

As used herein, the term “agent” means any organic substance, inorganicsubstance, inert or biologically active substance of pharmacologicmaterial, that may effect or enhance tissue healing, reduce infection,reduce adhesions formation, modify the immunologic response, treatspecific disease processes, reduce pain or be used for any therapeuticor diagnostic purpose. This includes materials in solid, liquid or gasphase, and materials that are water (aqueous) based, colloid andnon-colloid suspensions, mixtures, solutions, hydrogels, lypholizedmaterials, hydrophobic, hydrophilic, anionic, cationic, surface activeagents, surgical adjuvants, anticoagulants, antibiotics, immunologicstimulators, immunologic suppressants, growth inhibitors, growthstimulators, diagnostic materials, anesthetic agents, analgesic agents,and materials by themselves or dissolved or based in other materials,such as, but not limited to, alcohols, ethers, esters, lipids andsolvents. The agent can be dry, such as in a power form. Any materialthat can be carried by the flow of gas into a body cavity or onto asurface for therapeutic or diagnostic purposes can be delivered inaccordance with this invention. It is not intended to limit the presentinvention to the above examples of agents. Furthermore, the gas streammay be treated with any type or combination of agents in accordance withthe present invention. An example is to treat the gas stream with ahumidifying solution for hydration to prevent desiccation, an antibioticto reduce infection, an anti-inflammatory to reduce inflammation and ananti-adhesive to reduce adhesions and improve healing. Agents such asthose sold under the trademarks Adept manufactured by ML Laboratories,Adcon manufactured by Gliatech and Atrisol manufactured by AtrixLaboratories can be used to reduce adhesions.

While in this embodiment, hydration fluids enter through valve 19, thetrocar could be packaged in a precharged condition with fluid containedin chamber 11 c. A recharge port could also be included in tubingleading to the trocar or placed anywhere on the trocar body such that afluid can reach chamber 11 c.

In the illustrated embodiment, conditioning media contains both a heaterand a porous material capable of absorbing water. In operation of thisembodiment of gas conditioning trocar 10, the insufflation gas and thehydration fluids are introduced into plenum chamber 11 a and flow in anaxial direction through the conditioning media 20 in chamber 11 c wherethe insufflation gas may be hydrated and heated to a temperature nearbody temperature for injection into the body cavity of a patient. As theinsufflation gas and hydration fluids flow through the conditioningmedia 20, the conditioning media 20 allows the insufflation gas to behydrated and/or heated immediately prior to injection of theinsufflation gas into the body cavity of a patient thus avoidingtransport loses that may occur with remote hydration units. A portion ofcannula 26 is typically inserted into a body cavity.

The conditioned insufflation gas flows from lower plenum chamber 11 binto passage 26 through annular inlet port 21 a. A surgical instrumentmay be passed through instrument inlet 28, into passage 21 a and,through cannula 26 and out the end 27 of cannula 26. The instrument maybe withdrawn and other instruments may be used in a similar fashionthroughout the procedure. As such, the delivery of conditionedinsufflation gas and the use of surgical instruments may occursimultaneously without adversely affecting or interfering with eachother.

In some embodiments, the insufflation gas may only be hydrated and theheater in conditioning media can be omitted. In other embodiments, theinsufflation gas may only be heated and the conditioning media 20 may beomitted. In other embodiments, a material capable of filteringinsufflation gas may be used as conditioning media 20 with or without aheater. Thus, the invention further includes a trocar 10 with only aninsufflation gas filter in cavity 11 c.

FIG. 2 shows a top view of the trocar housing 12 revealing an inletinstrument port 28, which is located in the center of housing 12. Inthis embodiment, extending across instrument port 28 is a closurecomprising a plurality of segment shaped resilient flaps 28 a thatnormally extend radially inward in tube 21 to block passage 21 a andthereby inhibit or prevent backflow of insufflation gas therepastwhether or not a surgical instrument is present in trocar 10. Theclosure may comprise a duckbill opening or lever valve. When a surgicalinstrument is inserted into trocar 10 the flaps 28 a flex to allow theinstrument to enter and pass through passage 21 a in tube 21.Preferably, the flaps 28 a are made of a resilient material such thatthey form a gas seal around the exterior surface of the surgicalinstrument therein to inhibit or prevent insufflation gas from escapingtherepast when the surgical instrument is located in trocar 10. If thesurgical instrument is withdrawn from tube 21, then the flaps 28 areturn to the closed condition shown in FIG. 1 to inhibit or preventinsufflation gas (e.g., conditioned gas) from escaping throughinstrument inlet port 28. A further benefit is that the flaps 28 a mayprevent contaminants from inadvertently entering trocar 10. Whileresilient flaps are shown comprising the closure other methods and meansmay be used to close off the instrument port to inhibit or preventbackflow of insufflation gas therepast. Any technique for doing so maybe used without departing from the scope of the invention.

In the example shown the on-the-go and in situ heating and hydrating ofthe insulation gas takes place in conditioning media 20 which is locatedin the annular chamber in the gas conditioning trocar 10.

FIG. 3 shows a side view of an example of a strip of a conditioningmedia 20 for bringing an insufflation gas into a conditioned state.Media 20 comprises multiple layers i.e. a multilayer media, in anunwound or unassembled condition. In the example shown the materials ofmultilayer media 20 include a layer of gas transfer material comprisingnetting 32 and a layer of a fluid transferring material comprisinghydrophilic material 30 with a heater assembly 34 extendingtherebetween. Heater assembly 34 includes a temperature sensor 22 on oneend and a pair of electrical leads 14 on the opposite end for connectionto a power source. Although three layers are shown the number andcomposition of the layers of material as well as the thickness of thelayers may be modified according to the specific application.Temperature sensor 22 may be part of heater assembly 34 or may beseparately mounted in trocar 20 to monitor the temperature of the heateror of the insufflation gas before the insufflation gas is dischargedfrom the trocar 20. Additional temperature sensors 22 may be includedand control circuitry to control the heater such that the insufflationgas temperature is maintained within a temperature range may be locatedwithin junction box 16 or remotely from the heater assembly 34 andtemperature sensors.

One or all of the above components can be omitted from conditioningmedia without departing from the scope of the invention. As noted above,some embodiments may have a filtering media, some may omit the heater,and some may include only a heater and no other media. Any arrangementof the heater, temperature sensor and absorbent material may be usedwithout departing from the scope of the invention. The media may bearranged to allow gas to primarily flow over or primarily flow throughthe media. The heater may be located in chamber 11 c or in any otherchamber of trocar 10 where the insufflation gas can be treated.Preferably, the gas will be heated substantially simultaneously as shownbut could be heated and humidified separately.

FIG. 4 shows the example strip of multilayer media 20 comprises aplurality of three layers of materials 30, 32 and 34 which may be woundinto a spiral configuration that may be inserted into the annularchamber in trocar 10. In the spiral configuration state, as shown inFIG. 4, the hydrating liquid may be brought into proximity of a heaterassembly 34 through an absorbing action of a hydrophilic layer 30 inmedia 20. The absorbing action allows distribution of the hydratingliquid proximate the heater assembly 34. Similarly, a porous netting 32may allow the insufflation gas to flow threrethrough so the gas can bebrought into proximity of the heater assembly 34 to enable theinsufflation gas to be brought to a conditioned state.

FIG. 4A is a cross sectional view of the spirally wound media 20 takenalong lines 4A-4A of FIG. 4 revealing the multiple layers comprising theconditioned media 20.

In order to secure the multilayer media 20 in the housing 12 themultilayer media 20 may be wound into a diameter slightly larger thanthe diameter of housing 12 to enable one to friction fit multilayermedia 20 in housing 12. If frictional forces are used to hold multilayermedia 20, then the multilayer media should be selected to offersufficiently low flow resistance so that the insufflation gas flowflowing thereto will not displace the multilayer media 20.

Alternatively, multilayer media 20 could be adhesively secured tohousing 12. It is noted that an advantage of the friction fit ofmultilayer media 20 in housing 12 is that the friction fit reduces theneed for an adhesive to hold multilayer media 20 in place. An adhesivemay interfere with the flow of insufflation gas from one layer ofmultilayer media 20 to another. An alternate method of holding themultilayer media 20 in position may be to use a radial supports inchamber 11 b to support the lower end of multilayer media 20. Othermethods of securing the multilayer media 20 may also be used to maintainthe multilayer media 20 in position to deliver hydrated insufflation gasto annular outlet port 21 a.

To decrease the pressure drop through netting 32 two or more layers ofnetting may be placed proximate each other to increase the porositythough the netting. That is, netting 32 provides flow passages for theinsufflation gas to flow from plenum chamber 11 a to plenum chamber 11 bwithout undue but sufficient resistance so that the hydration fluid andthe hydration gas can be maintained in proximity to enable hydration totake place in embodiments where hydration is performed. A suitablenetting 32, for example, is a bi-planar polypropylene netting havingproperties including a density of 11 strands per inch and a thickness of0.030 inches (e.g., Delstar, Middleton, Del.). Any netting capable ofallowing gas flow could be used without departing from the scope of theinvention. Also, the netting 32 could be omitted.

Multilayer media 20 may include at least one layer of a liquid transfermedia, which for example may be a hydrophilic media 30, that readilyabsorbs and retains a volume of hydration fluid provided to plenumchamber 11 a. While other types of materials, for example wickingmaterials, may be used to deliver the hydration fluid into proximity ofthe heater assembly 34, the hydrophilic media 30 may bring the hydrationfluid in close proximity to both heater assembly 34 and the insufflationgas through an absorbing action. Similarly, two or more layers ofhydrophilic material may be used to bring the hydration liquid proximatethe heater assembly.

Hydrophilic media 30 may be thin and flexible so that it is easily woundin a spiral configuration with the other layers of multilayer media 20as shown in FIG. 4. Although many types of hydrophilic material areuseable, a typical suitable hydrophilic media 30 is cellulose which iscommercially available from Knowlton, Watertown, N.Y. having thefollowing characteristics: a basis weight of 91-99 pounds/3000 ft² and athickness of about 0.028-0.034 inches.

The multilayer media 20 may include a heater assembly 34, which maycomprise an elongated flexible heating element that has externalelectrical leads 44 for connecting to a source of electrical power. Theheater assembly 34 may be thin and flexible such that when it issandwiched between the hydrophilic layer 30 and the layer of netting 32the combination can be wound into a spiral configuration that can beinserted within housing 12. An advantage of the spiraled configurationis that it provides a continuous extended area for heating and hydrationof the insufflation gas, i.e., the insufflation flow path is long. Inthe preferred embodiment, heater assembly 34, for example, is aresistance heating element made of etched copper foil coated with alayer of polyimide. Another layer of polyimide may coat the foilsurface. The coating of polyimide reduces the likelihood of heaterassembly 34 from contacting the hydration fluid or hydrated gas suchthat an electrical short results. As discussed above, however, any typeof heater and any type of absorbent material may be used with theinvention.

One end of heater assembly 34 may terminate with a temperature sensor 22for measuring the temperature of the heater in the gas conditioningtrocar 10. In other embodiments, multiple temperature sensors may beused and may be located elsewhere to sense the temperature of the gasdirectly rather than sensing the temperature of the heater. Thetemperature sensor can be located in one of the chambers 11 b or 11 c orlocated in the cannula 26. In some cases, a remote sensor (e.g. anelectronic infrared sensor) exterior to the trocar could be used. Whenheater assembly 34 is layered with the other materials of multilayermedia 20 and friction fit into housing 12, temperature sensor 22, forexample a thermistor, detects the temperature of the heater at lowerplenum chamber 11 b. A heater control, not shown, can increase ordecrease the power supplied to heater assembly 34 to maintain thetemperature within a desirable range for injection into a body cavity.The opposite end of heater assembly 34 may terminate with electricalleads 14 which can be connected to a power source. When heater assembly34 is layered with netting 32 and hydrophilic media 30 and assembledinto a spiral configuration, electrical leads 14 may extend beyond themultilayer media 20. Thus, when the multilayer media 20 is placed inhousing 12, the electrical leads 14 may extend beyond housing 12 forconnection to a source of electrical power as shown in FIG. 1.

In the preferred embodiment, multilayer media 20 is assembled into aspiral configuration (FIG. 4) although other configurations may be used.An advantage of the spiral configuration is that the hydrating fluid andinsufflation gas are brought in to close proximity to the heaterassembly 34 as they flow from annular plenum chamber 11 a to annularplenum chamber 11 b. Although an annular conditioning media 20 whichextends from side to side is shown, the gas conditioning media may takeother shapes or forms which allow the insufflation gas to be conditionedwithin the trocar. For example, only a portion of the annular chamber inthe trocar may be used for the conditioning of the gas. A furtherbenefit and advantage of use of a multilayer media is that multilayermedia 20 can more easily be assembled in a flat condition andsubsequently wound into a spiral configuration for insertion into theannular chamber of the trocar 10.

Referring to FIG. 1, an elongated cylindrical passages 21 a and 26 aextend along a central axis 25 of trocar 10. Passages 21 a and 26 a areof adequate diameter to simultaneously house a surgical instrument andallow a flow insufflation gas without undue fluid resistance thereto.

Trocar 10 may include a closure such as a hinged flap 24, which isnormally held in a closed position by a spring 24 a to prevent backflowof bodily fluids or other materials from the patient's body cavity. Flap24 opens in response to a medical instrument being inserted intopassages 26 a. It is noted that while flap 24 is the preferredembodiment, other methods or structures may be used to prevent backflow.

We claim:
 1. A gas conditioning trocar for use during a medicalprocedure comprising: a housing having an instrument passage forinsertion of a surgical instrument therein; an annular chamber locatedin said housing; an annular inlet plenum chamber located in a firstportion of said chamber for receiving an unconditioned insufflation gas;an annular outlet plenum chamber located in a further portion of saidchamber for receiving a heated and hydrated insufflation gas; a cannulafor insertion into a body cavity wherein the instrument passage extendsthrough the annular chamber and the cannula; and a spiral woundconditioning media comprising a plurality of layers of materials with aone of the plurality of layers of materials carrying a hydration fluidtherein, said spiral wound gas conditioning media located within saidannular chamber and between said annular inlet plenum chamber and saidannular outlet plenum chamber with a first end of the spiral woundconditioning media in fluid communication with the annular inlet plenumchamber and an opposite end of the spiral wound conditioning media influid communication with the annular outlet plenum chamber therebyforming an end to end insufflation gas flow path from an end of thespiral wound conditioning media in the inlet plenum chamber to anopposite end of the spiral wound media in the outlet plenum chamberwherein the insufflation gas flows between and along the plurality oflayers of materials of the conditioning media located in the annularchamber as the conditioning media hydrates the insufflation gas byabsorbing the hydration fluid into the insufflation gas as theinsufflation gas flows alongside the one of the plurality of layers ofmaterials carrying the hydration fluid, said spiral wound conditioningmedia including an electrical heater with the insufflation gas flow pathlocated on opposite sides of the electrical heater for heating theinsufflation gas within the spiral wound conditioning media beforedelivery of the heated and hydrated insufflation gas to a body cavity ofa patient.
 2. The gas conditioning trocar of claim 1 including atemperature sensor located within the chamber to monitor the temperatureof the insufflation gas.
 3. The gas conditioning trocar of claim 2wherein the temperature sensor comprises a thermistor.
 4. The gasconditioning trocar of claim 1 wherein the conditioning media comprisesa multilayer media comprising a hydrophilic layer and a layer ofnetting.
 5. The gas conditioning trocar of claim 4 wherein the media ismaintained in the chamber through a friction fit within the housing. 6.The gas conditioning trocar of claim 4 wherein the hydrophilic layercomprises cellulose.
 7. The gas conditioning trocar of claim 4 whereinthe netting comprises polypropylene.
 8. The gas conditioning trocar ofclaim 4 wherein the netting comprises a bi-planar netting.
 9. The gasconditioning trocar of claim 1 wherein the electrical heater comprises aresistance heating element.
 10. The gas conditioning trocar of claim 9wherein the resistance heating element comprises an etched copper foilcoated with a layer of polyimide.
 11. The gas conditioning trocar ofclaim 9 wherein the resistance heating element comprises an etchedcopper foil.
 12. The gas conditioning trocar of claim 1, furthercomprising a closure that extends across the instrument port with theclosure sealing against a surgical instrument extending through theinstrument port to inhibit loss of the insufflation gas.
 13. The gasconditioning trocar of claim 12 wherein the closure comprises aplurality of flaps that remain closed when the instrument passage isvacant.